Nonsense. Regulators don't play when people's lives are on the line. They won't let someone run a trial to experiment on people without any sort of chance said trial can be used for approval. This narrative is laughable. Regulators don't run a circus like you want to portray in your posts.
Have a good holiday Ex! You recall our bet that you conveniently forgot about for the last few months?! I just saw you recently saying no submission this year.